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news.Health Canada has requested additional information in support of Osiris Therapeutics’ application for approval of stem cell therapy Prochymal for the treatment of graft vs. host disease (GvHD).
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Health Canada has given Osiris 90 days to answer certain questions raised during the review.
Osiris president and CEO Randal Mills said they intend to work with Health Canada to expeditiously provide them the additional information necessary to complete the application and make this important therapy available to patients in need.
Osiris Therapeutics’ pipeline of internally developed biologic drug candidates under evaluation includes Prochymal for inflammatory, autoimmune and cardiovascular indications, as well as Chondrogen for arthritis in the knee.
Osiris and Genzyme formed a strategic alliance for the development and commercialization of Prochymal and Chondrogen.
Under the terms of the agreement, Osiris retains commercialization rights to Prochymal and Chondrogen in the US and Canada.
Genzyme holds these rights in all other countries except Japan, where JCR Pharmaceuticals holds rights to Prochymal for the treatment of patients with hematological malignancies.
Last year, Health Canada has granted Prochymal Priority Review.